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A Trial of Cognitive Training in Euthymic Bipolar Disorder

Primary Purpose

Bipolar Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Working memory training
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Disorder focused on measuring Cognitive training, Working memory, Emotion regulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female
  • Age between 18 and 65 years
  • Clinically diagnosed with bipolar disorder I or bipolar disorder II and currently in a euthymic state
  • Normal, or corrected to normal, vision and hearing
  • Able to provide informed consent

Exclusion Criteria:

  • Meeting Diagnostic and Statistical Manual 5th edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode
  • Past electroconvulsive therapy (ECT)
  • Past Transcranial Magnetic Stimulation therapy (TMS)
  • Past 3 month history of substance abuse
  • Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)
  • Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)

Sites / Locations

  • Foothills Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive training

Control

Arm Description

The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). The experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games provided by BrainGymmer are adaptive, meaning that the level of difficulty increases as users develop expertise on a given task. Participants randomized to the cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.

The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, participants will complete post-testing assessments.

Outcomes

Primary Outcome Measures

Working memory capacity
Measured with the Automated Operation Span task (AOSPAN), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span and Maintenance and Manipulation task
Emotion regulation
Measured with the Emotional Stroop task and Emotional N-back task
Fluid intelligence
Measured with the Raven's Progressive Matrices (RPM) task

Secondary Outcome Measures

Depression symptom severity
Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)
Manic symptom severity
Measured with the Young Mania Rating Scale (YMRS)
Community functioning
Measured with the Functioning Assessment Short Test (FAST)

Full Information

First Posted
June 15, 2015
Last Updated
May 14, 2016
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02476331
Brief Title
A Trial of Cognitive Training in Euthymic Bipolar Disorder
Official Title
A Randomized Control Trial of Cognitive Training in Euthymic Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Student no longer enrolled in program.
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Bipolar disorder (BD) is characterized by extreme changes in mood and emotion dysregulation. Mood changes are episodic in nature, with distinct periods of mania, depression, and asymptomatic periods of euthymia. In addition to impairments in mood, cognitive impairments are a common feature of the disorder. These cognitive impairments persist during periods of euthymia and are associated with negative clinical and psychosocial outcomes. Specifically, individuals with BD show impairments in executive functions. Recent studies show that emotion regulation can be down-regulated by taxing executive functions, and it can be improved with working memory training, a specific component of executive functions. These initial studies show that emotion regulation is under executive control in healthy individuals; however, the nature of this relationship is not well understood in populations that are affected by impairments in both executive control and emotion regulation. Previous work on cognitive training has not targeted specific cognitive domains with an emphasis on understanding the underlying mechanisms that promote change. Moreover, well-controlled randomized control trial (RCT) studies are needed in order to provide high quality evidence to inform the efficacy of cognitive training interventions for psychiatric populations. The aim of the proposed study is to use a commercially available cognitive training program to study the effects of working memory training on cognitive, clinical, and psychosocial outcomes in patients with BD. We hypothesize that training working memory will lead to improvements in cognitive and emotional functioning, leading to downstream changes that will positively impact untrained outcomes, such as mood and community functioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Cognitive training, Working memory, Emotion regulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive training
Arm Type
Experimental
Arm Description
The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). The experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games provided by BrainGymmer are adaptive, meaning that the level of difficulty increases as users develop expertise on a given task. Participants randomized to the cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will wait 10-weeks, during which they will receive treatment-as-usual (TAU), which might involve pharmacotherapy, psychotherapy, or both. After the 10-week waiting period, participants will complete post-testing assessments.
Intervention Type
Behavioral
Intervention Name(s)
Working memory training
Intervention Description
The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). The experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games provided by BrainGymmer are adaptive, meaning that the level of difficulty increases as users develop expertise on a given task. Participants randomized to the cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
Primary Outcome Measure Information:
Title
Working memory capacity
Description
Measured with the Automated Operation Span task (AOSPAN), Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span and Maintenance and Manipulation task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Emotion regulation
Description
Measured with the Emotional Stroop task and Emotional N-back task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Fluid intelligence
Description
Measured with the Raven's Progressive Matrices (RPM) task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Secondary Outcome Measure Information:
Title
Depression symptom severity
Description
Measured with the 17-item Hamilton Rating Scale for Depression (HRDS-17)
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Manic symptom severity
Description
Measured with the Young Mania Rating Scale (YMRS)
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Community functioning
Description
Measured with the Functioning Assessment Short Test (FAST)
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Other Pre-specified Outcome Measures:
Title
Decision making and impulsivity
Description
Measured with the Delay Discounting Task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Executive functioning: inhibition and set shifting
Description
Measured with the Delis-Kaplan Executive Functions System (D-KEFS) Color-Word Interference Test
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Executive functioning: categorization and set-shifting
Description
Measured with D-KEFS Sorting Test
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Theory of mind reasoning
Description
Measured with Hinting Task
Time Frame
Change from baseline to post-assessment (after 10 weeks of training)
Title
Motivation
Description
Measured with the Intrinsic Motivation Inventory
Time Frame
Throughout the 10 weeks of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Age between 18 and 65 years Clinically diagnosed with bipolar disorder I or bipolar disorder II and currently in a euthymic state Normal, or corrected to normal, vision and hearing Able to provide informed consent Exclusion Criteria: Meeting Diagnostic and Statistical Manual 5th edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode Past electroconvulsive therapy (ECT) Past Transcranial Magnetic Stimulation therapy (TMS) Past 3 month history of substance abuse Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease) Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vina Goghari
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25379283
Citation
Lawlor-Savage L, Goghari VM. Working memory training in schizophrenia and healthy populations. Behav Sci (Basel). 2014 Sep 3;4(3):301-319. doi: 10.3390/bs4030301. eCollection 2014 Sep.
Results Reference
background
Links:
URL
http://braintrainingstudy.ca/
Description
Click here for more information about this study: A Randomized Control Trial of Cognitive Training in Bipolar Disorder

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A Trial of Cognitive Training in Euthymic Bipolar Disorder

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